Safety, Tolerability, and Immunogenicity of an Investigational Vaccine With Recombinant Human Albumin (rHA) in Children 12 to 18 Months of Age (V205C-009)(COMPLETED)

A Comparison of the Safety, Tolerability, and Immunogenicity of V205C Manufactured With Recombinant Human Albumin (rHA) Versus V205C Manufactured With Pooled-Donor Human Serum Albumin (HSA) in Healthy Children 12 to 18 Months of Age

Status

Completed

Phases

Phase 2

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00092404

Enrollment

1210

Registered

2004-09-27

Start date

2001-12-31

Completion date

2005-06-30

Last updated

2017-03-15

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Measles, Mumps, Rubella, Varicella

Brief summary

The purpose of this trial is to study the safety and immune response to measles, mumps, and rubella in children who were vaccinated with an investigational measles-mumps-rubella live vaccine made with artificially made human protein.

Detailed description

The duration of treatment is 6 weeks.

Interventions

BIOLOGICALmeasles, mumps, and rubella virus vaccine live

BIOLOGICALComparator: Measles, Mumps, and Rubella Virus Vaccine Live

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

PREVENTION

Masking

DOUBLE (Subject, Investigator)

Eligibility

Sex/Gender

ALL

Age

12 Months to 18 Months

Healthy volunteers

Yes

Inclusion criteria

* Healthy children 12 to 18 months of age

Exclusion criteria

* History or prior exposure to measles, mumps, or rubella * History of allergic reactions to any component of the vaccines as evaluated by the study doctor

Design outcomes

Primary

Measure	Time frame
Antibody response rates to measles, mumps, and rubella at 6 weeks postvaccination	6 weeks postvaccination

Secondary

Measure	Time frame
Geometric mean titers to measles, mumps, and rubella by ELISA at 6 weeks postvaccination	6 weeks postvaccination

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026